Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Clinical Worsening and Suicide Risk
Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.

Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms.

Risk of suicide Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication.

Patients should be made aware that Zyban contains the same active ingredient found in WELLBUTRIN, WELLBUTRIN SR, and WELLBUTRIN XL used to treat depression and that Zyban should not be used in conjunction with WELLBUTRIN, the immediate-release formulation; WELLBUTRIN SR, the sustained-release formulation; WELLBUTRIN XL, the extended-release formulation; or any other medications that contain bupropion hydrochloride.

BLACK TRIANGLE This medicinal product is subject to additional monitoring. This will allow quick identification of new safety information. Healthcare professionals are asked to report any suspected adverse reactions. See section 4.8 for how to report adverse reactions. (NB Black Triangle now removed having checked the SPC 3rd May 2017)

FDA Warnings Suicidal ideation and behaviour
November 2007 - FDA announced it had received post-marketing reports that patients using Chantix for smoking cessation had experienced several serious symptoms, including suicidal ideation and occasional suicidal behaviour, erratic behavior, and drowsiness.

February 1, 2008 FDA - Neuropsychiatric symptoms have occurred in patients being treated with Chantix. Some cases may have been complicated by the symptoms of nicotine withdrawal in patients who stopped smoking; however, some of these symptoms have occurred in patients who continued to smoke.

All patients being treated with Chantix should be observed for neuropsychiatric symptoms including changes in behavior, agitation, depressed mood, suicidal ideation and suicidal behavior.

These symptoms, as well as worsening of pre-existing psychiatric illness, have been reported in patients attempting to quit smoking while taking Chantix in the postmarketing experience.

Withdrawing
At the end of treatment, discontinuation of CHAMPIX was associated with an increase in irritability, urge to smoke, depression, and/or insomnia in up to 3% of patients. The prescriber should inform the patient accordingly and discuss or consider the need for dose tapering

Reporting Adverse Drug Reactions (ADRs)

It is well known that serious side effects of medicines are under reported and the UK regulatory body the Medicines and Healthcare Regulatory Agency (MHRA) estimate less than 10% of serious ADRs are reported.

If you are, for no apparent reason, feeling mentally distressed, it may be caused by starting or stopping medication, due to a changed dose, withdrawal effects, interactions with other drugs, or following surgery. You can request a list of drugs used pre surgery and during surgery and those for pain or infection to be taken later.

You should be given a patient information leaflet (PIL) for all drugs prescribed, either as you are discharged from hospital, or if the pharmacy supplies you from a bulk supply of pills. (EU Directive 1997)